Cancer

Kathy S. Albain

Patients must have histologically or cytologically proven newly diagnosed Stage IV, as defined in Section 4.0, advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified) or recurrent disease after previous surgery and/or irradiation. Patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease will not be considered to have Stage IV disease and are not eligible.
5.2 Patients with controlled (for a minimum of two months) brain metastases after treatment and no residual neurological dysfunction off corticosteroids are eligible. All patients must have a pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to registration.
5.3 Patients may have measurable or non-measurable disease (see Section 10.1)
documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality as defined in Section 10.1a. Measurable disease must be assessed within 28 days prior to registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form (Form #848). See Sections 15.2 and 19.6 for guidelines and submission instructions for required central radiology review.
5.4 Translational medicine studies: Patients must agree to submission of specimens for EGFR FISH testing and other translational medicine studies as outlined in Section 15.0.
Patients must be offered participation in banking for future research.
5.5 Patients must not have received for any purpose prior chemotherapy, cetuximab, gefitinib, erlotinib or other investigational agents that target the EGFR pathway. Patients must not have received for any purpose prior VEGF-related agents. Patients must not have received for any purpose prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA).
5.6 Prior radiation is permitted; however, patients must have recovered from all associated toxicities at time of registration. In order to qualify as measurable per Section 10.1a, measurable disease must be outside the previous radiation field or must have progressed.
Open biopsy or significant traumatic injury and patients must have recovered from all associated toxicities at the time of registration. There must be no anticipation of need for major surgical procedures during protocol treatment. Patients must not have had a core biopsy within seven days prior to registration.
5.8 Patients must have an ANC = 1,500/mcl, platelet count = 100,000/mcl and hemoglobin =9 mg/dL obtained within 14 days prior to registration.
5.9 Patients must have a serum creatinine = institutional upper limit of normal (IULN) AND calculated or measured creatinine clearance = 50 cc/min using the following Cockroft-Gault Formula:
Estimated creatinine clearance = (140 - age) X (actual body weight in kg).
72 x serum creatinine. Multiply this number by 0.85 if the patient is a female.
These tests must have been performed within 14 days prior to registration.
5.10 Urine protein must be screened by urine analysis for urine protein creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be

Purpose

The primary objective of this study is
in patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare
overall survival (OS) in the entire study population; progression-free survival (PFS) by institutional review in EGFR FISH-positive patients.
The secondary objectives are in patients with advanced NSCLC treated with carboplatin, paclitaxel and bevacizumab (if appropriate) with or without cetuximab, to compare OS and PFS by centralized review in EGFR FISH-positive patients; PFS by centralized image review and by institutional review in the entire study population.
To compare the response rate (confirmed plus unconfirmed, complete and partial responses) in the subset of patients with measurable disease in
EGFR FISH-positive patients; the entire study population.
The purpose of this study is to compare the effects, good and/or bad, of cetuximab on lung cancer.